Back to resultsTrial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Liatermin
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring bilateral, idiopathic Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: - Completion of the 20020168 protocol
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liatermin
Arm Description
Bilateral continuous infusion of liatermin for up to 24 months.
Outcomes
Primary Outcome Measures
Percent change in UPDRS
Secondary Outcome Measures
Incidence of treatment emergent and device related adverse events
Full Information
NCT ID
NCT00111982
First Posted
May 27, 2005
Last Updated
February 25, 2010
Sponsor
Amgen
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00111982
Brief Title
Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin
Official Title
Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
Collaborators
Medtronic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
bilateral, idiopathic Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liatermin
Arm Type
Experimental
Arm Description
Bilateral continuous infusion of liatermin for up to 24 months.
Intervention Type
Biological
Intervention Name(s)
Liatermin
Intervention Description
Liatermin
Primary Outcome Measure Information:
Title
Percent change in UPDRS
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Incidence of treatment emergent and device related adverse events
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Completion of the 20020168 protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin
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